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Trial ID or NCT#

NCT00780494

Status

NOT RECRUITING

Purpose

To investigate bevacizumab in combination with carboplatin and capecitabine for patients with
unresectable or metastatic GEJ or gastric cancers. We hope that by adding bevacizumab to
standard chemotherapy for this patient population we will improve Progression Free Survival
by 80% over historical controls.

Official Title

A Phase II Study of Capecitabine, Carboplatin, and Bevacizumab for Metastatic or Unresectable Gastroesophageal Junction and Gastric Adenocarcinoma

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

Inclusion Criteria:

Subjects must be treated at Stanford University Medical Center for the entire length of study participation.

Patients with histologically or cytologically confirmed adenocarcinoma of the GEJ or stomach.

Patients must be deemed unresectable due to involvement of critical vasculature or adjacent organ invasion. If unresectable, patients must show evidence of disease progression prior to enrollment.

Patients with prior surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases.

Prior carboplatin as neoadjuvant or adjuvant therapy will be allowed if >= 6 months from the time of study entry.

If patients use aspirin (>325mg/day) or NSAIDS at the time of enrollment, they must have a 10 day washout period prior to beginning protocol treatment.

Low molecular weight heparin (or its equivalent, excluding warfarin) will be allowed for treatment of venous thromboembolic events if patients have no evidence of bleeding on full-dose anticoagulation.

Patients must have a primary or metastatic lesion measurable in at least one dimension by Modified RECIST criteria (see Section 11.2.3) within 4 weeks prior to entry of study

Inclusion and exclusion criteria for DCE-MRI and DWI imaging will be determined by CT scan as part of routine post-chemotherapy imaging. Subjects will be eligible if one liver metastasis is greater than 1 cm in size. Participation in the DCE-MRI and DWI correlate is not required for eligibility.

Ability to give written informed consent according to local guidelines

Exclusion Criteria:

Disease-Specific Exclusions

Prior chemotherapy for metastatic disease

Prior full field radiotherapy <= 4 weeks or limited field radiotherapy <= 2 weeks prior to enrollment. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease.

Prior biologic or immunotherapy <= 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities

Prior therapy with anti-VEGF agents

If history of other primary cancer, subject eligible only if she or he has:

Curatively resected non-melanomatous skin cancer

Curatively treated cervical carcinoma in situ

Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years

Concurrent use of other investigational agents and patients who have received investigational drugs <= 4 weeks prior to enrollment.

Hypersensitivity to capecitabine, fluorouracil, or any component of the formulation and or a known deficiency of dihydropyrimidine dehydrogenase.

General Medical Exclusions

Subjects known to have chronic or active hepatitis B or C infection

History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study results

Male subject who is not willing to use adequate contraception upon enrollment into this study and for 6 months following the last dose of second-line treatment

Female subject (of childbearing potential, post-menopausal for less than 6 months, not surgically sterilized, or not abstinent) who is not willing to use an oral, patch or implanted contraceptive, double-barrier birth control, or an IUD during the course of the study and for 6 months following the last dose of second-line treatment

Female subject who is breast-feeding or who has positive serum pregnancy test 72 hours prior to randomization